· Provide governance in the implementation of the PT Quality Training system and GMP Regulations training.
· Lead the development and management of Quality training programs for Global Quality and Compliance and the overall PT organization
· Ensure GMP training reflects the requirements of the Pharmaceutical Quality System.
· Partner with functional area subject matter experts and leaders to deliver to predefined expectations
Job Description :
· Provide governance on the PT Quality Training system requirements, process
· Partner with leadership, PT Learning and functional area subject matter experts to deliver to learning results
· Provide QA and Compliance oversight and support for PT Learning team as it relates to CHRIS LSO.
· Drive the development and continual improvement of global Quality education/training programs in collaboration with the PT Learning organization. This includes but is not limited to:
o Partner with internal groups (External collaborations, inspection management, Audit, etc.) to help identify and analyze training needs
o Lead the management of the Global Quality Certification Program (US and Europe). Ensure program content remains current, execute annual application process
o Develop, maintain and manage the Global Investigator Certification Program
o Define the strategy, develop and deploy GMP Regulations training courses for all PT employees. Ensure current and new GMP and Health Authority regulations are incorporated into training courses.
o Develop, maintain and manage a Quality Training Program for Managers
· Utilize standard tools and consistent methodology in the development of training programs
· Monitor and evaluate training activities and program effectiveness
· Independently identify and recommend solutions to procedural, process and system gaps in support of departmental and organizational process improvements
· Maintain effective working relationships with local and global stakeholders
· Develop and report training related metrics to raise awareness of training compliance
· Stay aware of GMP trends and suggest new training to ensure PT is positioned to keep current with GMPs. · BA/BS in Scientific and Technical discipline, with 8-11 years experience in healthcare/biotech/pharmaceutical industry
· Ability to understand and interpret cGMP, the relationship with PQS to ensure training materials support continual learning
· Extensive knowledge of manufacturing, cGMPs and compliance topics
· Knowledge of adult learning theory and learning design
· Strong Quality orientation with attention to detail and delivery of service excellence
· Must work well in a collaborative team environment and communicate effectively with all levels of the organization, demonstrating excellent written and verbal communication skills
· Create and manage work plans and timelines and establishes own priorities and can manage parallel activities simultaneously
· Demonstrated influencing and interpersonal skills, and the ability to work well with others in a proactive, positive and constructive manner
Roche - 19 months ago
Roche is on a medicinal roll. The company operates two segments, pharmaceuticals and diagnostics, and sells its products in some 180...